GMY — Antisera, Fluorescent, All Types, Escherichia Coli Class I

FDA Device Classification

FDA product code GMY covers "Antisera, Fluorescent, All Types, Escherichia Coli", a Class I medical device regulated under 21 CFR 866.3255. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.